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A Study to Assess the Effects of an Oral Dietary Supplement on Overall Facial Appearance Among Healthy Adult Women With Existing Skin Damage From Sun Exposure

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ClinicalTrials.gov Identifier: NCT01787461
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The study hypothesis is that Imedeen will show effects on skin health, when compared to placebo over a 6 month intervention period with respect to changes in skin appearance, skin density, moisture, and in fine lines and wrinkles.

Condition or disease Intervention/treatment Phase
Photodamaged Skin Dietary Supplement: Imedeen Dietary Supplement: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Double-blind, Placebo Controlled Trial Assessing The Effects Of An Oral Dietary Supplement Containing Marine And Plant Extracts On Overall Facial Skin Appearance Among Healthy Adult Women With Photo-aged Skin
Study Start Date : January 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Imedeen
Imedeen is the study product
 Dietary Supplement: Imedeen
Two tablets per day for 6 months
Other Name: Imedeen Time Perfection
Placebo Comparator: Placebo Dietary Supplement: Placebo
Two tablets per day for 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24 [ Time Frame: Baseline, Week 24 ]
    IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.


Secondary Outcome Measures :
  1. Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24 [ Time Frame: Week 24 ]
    IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).

  2. Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12 [ Time Frame: Baseline, Week 12 ]
    IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.

  3. Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
    Investigator performed the assessment of face (Fine lines/wrinkles (L/W) of the periocular area (A), Fine lines/wrinkles of the perioral area, dark circles (dc) or "bags" under the eye, mottled hyperpigmentation (MH), sallowness/yellowing, roughness/texture) using a numerical severity rating scale of 0 to 9, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.

  4. Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
    Investigator performed the assessment of decolletage and back of hands (crepyness, mottled hyperpigmentation [MH]) using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.

  5. Participants Improvement Assessment of Face at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
    Participants performed the assessment of face (overall facial (OA) appearance, fine lines and wrinkles (L/W) present in the eye area, upper lip, or cheek areas, under eye dark circles (dc) or bags, discoloration [uneven, patchy, blotchy areas of light and dark, age spots, liver spots], complexion/glow [bright radiant appearance] and smoothness) at Baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the facial parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).

  6. Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
    Participants performed the assessment of decolletage (decolletage overall, decolletage-wrinkling/crinkling (W/C), decolletage-discoloration (DD) and back of hands (back of hands overall, back of hands (BOH) - Fine lines/wrinkles (L/W), back of hands - discoloration) and Body - Dryness (BD) Overall at baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the Decolletage, Back of Hands and Body parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).

  7. Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 [ Time Frame: Baseline, Week 6, 12, 18, 24 ]
    DermaLab Combo Skin Lab with an 8-pin probe was used to measure hydration (corneometry). Hydration measurements of the left cheek, left inner arm, and left outer arm were taken (up to 3 measurement).

  8. Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 [ Time Frame: Baseline, Week 6, 12, 18, 24 ]
    Trans-epidermal water loss (TEWL) measurements were done using DermaLab Combo SkinLab with a cylindrical diffusion chamber (10 mm [millimeter] diameter) containing 2 combined humidity/temperature sensors to determine the amount of water vapor that moves across the stratum corneum. TEWL measurements were taken on the left cheek and the left inner and outer arm (up to 3 measurement).

  9. Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 [ Time Frame: Baseline, Week 6, 12, 18, 24 ]
    Skin thickness was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).

  10. Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) [ Time Frame: Baseline, Week 6, 12, 18, 24 ]
    Skin density was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system with 100 percent (%) calibration mode. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

In general good health and have no contraindications to the study product; Have Fitzpatrick Skin Type I-IV as determined by a trained evaluator. Have Glogau Classification of Photoaging of II or III as determined by the investigator.

Exclusion Criteria:

Use of any dietary supplement, over-the-counter or prescription product with the indication of improving the appearance or condition of the skin within one month of baseline.

History of or current disease or condition of the skin that the investigator deems inappropriate for participation (eg, atopic skin, facial scars, psoriasis, eczema, other scaly inflammatory diseases).

Subjects who have had a facial cosmetic procedures (eg, fillers, toxins, facial peel) or invasive surgical procedures (eg, laser treatment or face lift) or other facial treatments by a physician or skin care professional within the last 6 to 9 months from baseline (pending procedure type) or plan to have a treatment during the study.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787461


Locations
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United States, Florida
Baumann Cosmetic and Research Institute
Miami, Florida, United States, 33137
United States, New Jersey
TKL Research, Inc.
Fair Lawn, New Jersey, United States, 07410
United States, Virginia
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501
McDaniel Institute of Anti-Aging Research
Virginia Beach, Virginia, United States, 23462
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01787461    
Other Study ID Numbers: B5271003
First Posted: February 8, 2013    Key Record Dates
Results First Posted: March 18, 2015
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by Pfizer:
Trial assessing effects of an oral dietary supplement on overall facial appearance among healthy women with photodamaged skin.